EC approves Roche’s prophylaxis treatment for haemophilia A with factor VIII inhibitors

The European Commission (EC) has approved Roche’s routine prophylactic treatment in people with haemophilia A with factor VIII inhibitors, Hemlibra (emicizumab).

Hemlibra is a prophylactic treatment that can be administered by an injection of a ready-to-use solution under the skin (subcutaneously) once weekly. It can be administered to patients of any age group and has demonstrated efficacy compared with prior treatment with bypassing agents in two Phase III studies.

“This approval is great news for people in Europe with haemophilia A with inhibitors to factor VIII. The development of inhibitors not only puts them at greater risk of frequent and severe bleeds, but also makes the disorder more difficult to manage, with limited treatment options available to date,” stated Professor Johannes Oldenburg, Institute of Experimental Haematology and Transfusion Medicine, University of Bonn, Germany. “The bleed reduction and improvements in quality of life shown with Hemlibra compared to current treatments support its potential to advance the management of haemophilia A with inhibitors.”

“We're delighted that the European Commission has approved Hemlibra, providing people with haemophilia A with inhibitors a new medicine for the first time in over 20 years,” said Dr Sandra Horning, Roche's chief medical officer and head of Global Product Development. “We believe Hemlibra has the potential to make a meaningful difference in the lives of people with haemophilia A with inhibitors, and are committed to working with EU member states to provide access to this important medicine as quickly as possible.”